Monthly Archive for January, 2015

I’m sure ‘the kid in the garage without a degree’ is no dummy, but this premise:

And so that large percentage of medicine that is effectively being practiced by non-MDs is going to expand.

is simply ludicrous.

There’s a big difference between creating health and wellness appliances and mobile applications and diagnosing and treating patients. The distinction is outlined in FDA clarifies the line between wellness and regulated medical devices. If you claim your product acts like a doctor (treat or diagnose) or doesn’t fall into the “low risk” category, then your company will have to follow FDA regulatory controls.